Federated, Accessible, Inclusive, and Responsive Virtual Biorepository: Delphi Consensus Study

Background The reemergence of the Zika virus, the novel coronavirus, and new influenza strains highlighted the urgent need for an organized forum to access specimens to advance research, diagnostics, and vaccine development. During the COVID-19 pandemic, gaps in supply chains, communication, and standards between local (federated) and centralized systems cost time and lives. The FAIR-VBS (Federated, Accessible, Inclusive, and Responsive Virtual Biorepository) was proposed to connect communities with samples, address specimen-sharing challenges, and promote inclusion and equity. Objective This study aims to enable equitable contribution, sharing, and access to specimens while addressing the complexities involved. The objective is to build stakeholder consensus on prioritized actions, tools, and responsibilities to establish a functional and practical FAIR-VBS. Methods A Delphi process was conducted online to gather stakeholder input and develop a prioritized action plan for the FAIR-VBS. Respondents were recruited using snowball sampling, and questions were informed by participatory workshops, feedback, outreach efforts, and discussions to identify gaps and best practices. The Delphi process consisted of 2 rounds: an initial ranking informed by stakeholder input and a second round to refine priorities based on the panel feedback. Items were evaluated using a standardized 5-point Likert scale and retained if prioritized by at least 70% of respondents rating an item 4 or higher and no more than 15% rating an item below 2, with descriptive statistics applied. Advisory board discussions supplemented the virtual process to capture nuances, while qualitative data were analyzed using participatory action research methods. Results The Delphi process evaluated 34 cumulative items across 2 rounds to identify critical gaps and priorities in biorepository systems. In the first round, 22 out of 30 initial items successfully reached consensus. Panelists organically proposed 4 additional items during the first round; upon evaluation in the second round, 2 of these newly proposed items reached consensus, addressing benefit-sharing challenges (11/15, 73%) and the prioritization of whole blood, plasma, and serum samples (40/42, 95%). Culturally, peripheral blood mononuclear cells were supported as a secondary priority (13/18, 72%). In total, 24 items achieved consensus across both rounds, while 10 items overall did not. Respondents overwhelmingly supported the hybrid FAIR-VBS, which combines federated and centralized systems, offering local convenience with virtual oversight (34/41, 83%). Cost recovery for services was supported by all respondents (43/43, 100%), with a preference for a sliding fee scale to subsidize capacity building in low- and middle-income countries (40/42, 95%). Conclusions Respondents strongly supported the FAIR-VBS to enable equitable access to specimens, services, and benefits. They emphasized the need for clarity on benefit-sharing, regulatory, and ethical frameworks to ensure effective implementation and global inclusivity. A fair and equivalent system to enhance participation and operational continuity is being discussed.